What are the responsibilities and job description for the Senior Clinical Study Associate III position at Planet Pharma?
Job Description
- Participates in the day-to-day supervision of clinical trial execution, with a focus on site start up, patient enrollment, monitoring, and data flow metrics from the clinical sites, CROs and central labs
- Supports complex clinical trial activities in support of the Clinical Study Manager and other team members
- Prepare study documents (i.e. consent forms, site instructions, study specific materials such as the Manual of Operations, Pharmacy binder, etc.)
- Ensures tracking of essential documents are received and filed in the TMF, reviews site documents for accuracy; provides clinical team support with TMF filing and management
- Ensures tracking of patient status throughout the study at investigative sites
- Tracks and monitors sample collection, central laboratory reporting, and manages laboratory testing schedule
- Assists with laboratory vendor management and liaises with the CRO and clinical trial sites to ensure appropriate sample handling, shipment and result reporting
- Review monitoring trip reports, track data query reports, site visit metrics, and overall site performance
- Attends site initiation, routine monitoring and close-out visits at a limited # of clinical sites, as well as co-monitoring with CRO
- Ensures quality of the data generated from clinical sites and assists in resolving subject eligibility and protocol deviation issues
- Assists in the preparation of, and may present at investigator vendor meetings and workshops
- Actively involved in the performance of study feasibility assessments
- Review of site contracts and budgets for study start-up
- Coordinate the activities from third party vendors including metrics, accruals, process planning, and implementation
- Bachelors’ degree or higher
- 3 or more years of industry experience, working in Clinical Operations preferred
- Experience working in a global clinical trial
- Working knowledge in Good Clinical Practices (GCP) regulations and Standard Operating Procedures
- Understanding of study phases and general knowledge of how they apply to clinical development
- Advanced knowledge of Word, Excel, and PowerPoint.
- Knowledge of the principles and practices of computer applications in database management
- Strong verbal and written communication skills.
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